Layman Rachel M, Liu Xianchen, Li Benjamin, McRoy Lynn, Brufsky Adam
The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
Pfizer Inc, 66 Hudson Yards, New York, NY, 10001, USA.
Breast. 2025 Jun;81:104448. doi: 10.1016/j.breast.2025.104448. Epub 2025 Mar 17.
To examine the associations of palbociclib dose modifications with clinical outcomes of patients with HR+/HER2- metastatic breast cancer (MBC) treated with first-line (1L) palbociclib + aromatase inhibitor (AI) in routine practice.
Using the Flatiron Health Analytic Database, we conducted a retrospective analysis of HR+/HER2- MBC patients who started 1L palbociclib + AI February 2015-March 2020. Kaplan-Meier analyses were used to estimate treatment duration, real-world progression-free survival (rwPFS), and overall survival (OS) by palbociclib dose adjustments (any change in palbociclib daily dose while on treatment) and dose reductions (starting dose <125 mg/day or dose reduced while on treatment). Cox proportional hazard regression models were performed to compute unadjusted/adjusted hazard ratios (HRs).
Of 1302 patients with documented starting dose, 524 (40.2 %) had palbociclib dose adjustments; 778 (59.8 %) had none. Median treatment duration was significantly longer in patients with dose adjustments versus those with none (27.4 vs 21.4 months; adjusted HR = 0.80 [95 % CI, 0.69-0.93]; P = 0.004). Patients with and without dose adjustments showed similar median rwPFS (20.5 vs 19.6 months; adjusted HR = 0.89 [95 % CI, 0.76-1.04]; P = 0.133). Median OS was significantly prolonged in patients with versus without dose adjustments (57.8 vs 51.4 months; adjusted HR = 0.73 [95 % CI, 0.59-0.89]; P = 0.002). Similar findings were observed in patients with and without dose reductions.
In this real-world study, rwPFS in HR+/HER2- MBC patients was maintained irrespective of dose adjustments. However, dose adjustments were associated with extended treatment duration and OS.
NCT05361655 (ClinicalTrials.gov).
在常规临床实践中，研究哌柏西利剂量调整与接受一线（1L）哌柏西利联合芳香化酶抑制剂（AI）治疗的激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）转移性乳腺癌（MBC）患者临床结局之间的关联。
利用Flatiron Health分析数据库，我们对2015年2月至2020年3月开始接受1L哌柏西利联合AI治疗的HR+/HER2-MBC患者进行了回顾性分析。采用Kaplan-Meier分析方法，根据哌柏西利剂量调整（治疗期间哌柏西利每日剂量的任何变化）和剂量降低（起始剂量<125mg/天或治疗期间剂量降低）来估计治疗持续时间、真实世界无进展生存期（rwPFS）和总生存期（OS）。进行Cox比例风险回归模型计算未调整/调整后的风险比（HRs）。
在1302例有记录起始剂量的患者中，524例（40.2%）有哌柏西利剂量调整；778例（59.8%）没有。剂量调整患者的中位治疗持续时间显著长于未调整患者（27.4个月对21.4个月；调整后HR=0.80[95%CI，从0.69至0.93]；P=0.004）。有和没有剂量调整的患者中位rwPFS相似（20.5个月对19.6个月；调整后HR=0.89[95%CI，从0.76至1.04]；P=0.133）。有剂量调整的患者中位OS显著延长（57.8个月对51.4个月；调整后HR=0.73[95%CI，从0.59至0.89]；P=0.002）。在有和没有剂量降低的患者中观察到类似结果。
在这项真实世界研究中，无论剂量调整如何，HR+/HER2-MBC患者的rwPFS均得以维持。然而，剂量调整与延长治疗持续时间和OS相关。
NCT05361655（ClinicalTrials.gov）。
